Surgery and BCG in Treating Patients With Bladder Cancer
NCT ID: NCT00002990
Last Updated: 2013-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1288 participants
INTERVENTIONAL
1997-03-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.
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Detailed Description
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* Demonstrate that after complete transurethral resection of all papillary tumors, one third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose BCG and short term maintenance is equivalent to long term maintenance with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up.
* Demonstrate that one third dose BCG and short term maintenance are associated with fewer local and systemic side effects.
OUTLINE: This is a prospective randomized study.
At 7-15 days after transurethral resection, patients will begin receiving one of the following four regimens:
* Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12.
* Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12.
* Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30 and 36.
* Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30, and 36.
The patient is followed every 3 months for the first 3 years, and every 6 months thereafter.
PROJECTED ACCRUAL: 1288 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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BCG vaccine
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed transitional cell carcinoma of the bladder of the following types:
* Multiple (not greater than 10), resectable, T1 or Ta, grade G1-G3
* Solitary T1 GIII tumor
PATIENT CHARACTERISTICS:
Age:
* 85 and under
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Values used to evaluate function may not exceed two times the upper limit of normal
Renal:
* Values used to evaluate function may not exceed two times the upper limit of normal
Other:
* No second malignancy except basal cell skin carcinoma
* Not pregnant or nursing
* No uncontrollable urinary tract infection
* No active tuberculosis
* No HIV antibody
* No leukemia
* No Hodgkin's disease
* No transplant recipients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior treatment with BCG
Chemotherapy:
* No cytostatic agents within the past 3 months
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
85 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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A. P.M. Van Der Meijden, MD, PhD
Role: STUDY_CHAIR
Jeroen Bosch Ziekenhuis
Locations
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Kaiser Franz Josef Hospital
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Virga Jesse Hospital
Hasselt, , Belgium
AZ Groeninge - Oncologisch Centrum
Kortrijk, , Belgium
Hopital Edouard Herriot
Lyon, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
G. Hatzikosta General Hospital
Ioannina, , Greece
University of Patras Medical School
Rio Patras, , Greece
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Ospedale Di Desio
Milan, , Italy
Istituto Scientifico H. San Raffaele
Milan, , Italy
Azienda Ospedaliera Maggiore Della Carita
Novara, , Italy
Azienda Ospedale S. Luigi - Universita Di Turin
Orbassano, (Torino), , Italy
Universita Di Palermo
Palermo, , Italy
Universita Degli Studi Di Pisa
Pisa, , Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Amphia Ziekenhuis - locatie Langendijk
Breda, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Rijnland Ziekenhuis
Leiderdorp, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
St. Franciscus Gasthuis
Rotterdam, , Netherlands
Hospital Desterro
Amadora, , Portugal
Institute of Oncology - Bucarest
Bucharest, , Romania
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University School of Medicine
Izmir, , Turkey (Türkiye)
Celal Bayar University
Manisa, , Turkey (Türkiye)
St. James's University Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Countries
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References
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Cambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guerin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23.
Brausi M, Oddens J, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Side effects of Bacillus Calmette-Guerin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol. 2014 Jan;65(1):69-76. doi: 10.1016/j.eururo.2013.07.021. Epub 2013 Jul 24.
Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Hoeltl W, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guerin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013 Mar;63(3):462-72. doi: 10.1016/j.eururo.2012.10.039. Epub 2012 Nov 2.
Other Identifiers
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EORTC-30962
Identifier Type: -
Identifier Source: secondary_id
EORTC-30962
Identifier Type: -
Identifier Source: org_study_id
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